Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

NCT02919761 ↗

Phase 4 Completed 259 enrolled Mallinckrodt

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.

Timeline

Start: 2016-11-07
Primary completion: 2018-10-17
Completion: 2019-02-13

Outcome

Mixed primary results

paper The primary efficacy endpoint was the proportion of subjects who achieved LDA at week 12. PMID 32185745 ↗

paper At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001). PMID 32185745 ↗

registry COUNT_OF_PARTICIPANTS Part 2: Placebo: at Week 24: 47 Participants NCT02919761 ↗

registry COUNT_OF_PARTICIPANTS Part 2: Acthar Gel: at Week 24: 32 Participants NCT02919761 ↗

registry analysis (other test); Part 2: Placebo vs Part 2: Acthar Gel; p =0.019; Pearson's Chi-square test; note: Comparison at Week 24 NCT02919761 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	repository corticotropin injection	Unknown	80 iu	Subcutaneous